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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03440372




Registration number
NCT03440372
Ethics application status
Date submitted
14/02/2018
Date registered
22/02/2018
Date last updated
18/11/2024

Titles & IDs
Public title
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Scientific title
Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
U1111-1203-7225
Secondary ID [2] 0 0
RPC01-3201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ozanimod
Other interventions - Placebo

Experimental: Administration of oral Ozanimod -

Placebo comparator: Administration of Placebo -


Treatment: Drugs: Ozanimod
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of participants with average daily abdominal pain score = 1 point, and average daily stool frequency score = 3 points with abdominal pain and stool frequency no worse than baseline
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of = 50%
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150 and SES-CD decrease from baseline of = 50%
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline of = 50%
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Proportion of participants with an average daily abdominal pain score = 1 point, and average daily stool frequency score = 3 points and both no worse than baseline AND an SES-CD = 4 points and decrease =2 points
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Proportion of participants with an average daily abdominal pain score = 1 point, and average daily stool frequency score = 3 points and both no worse than baseline AND an SES-CD decrease from baseline of = 50%
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes)
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Proportion of participants with CDAI reduction from baseline of = 70 points
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10%
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50%
Timepoint [11] 0 0
Week 12

Eligibility
Key inclusion criteria
* Crohn's disease for = 3 months on endoscopy and on histological exam
* Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies
* Crohn's Disease Activity Index (CDAI) score = 220 and = 450
* An average daily stool frequency = 4 points and/or an abdominal pain of = 2 points
* Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of = 6 (or SES-CD = 4 in participants with isolated ileal disease)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
* Has extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
* Current stoma, ileal-anal pouch anastomosis, or fistula

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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NSW,QLD,SA,VIC,WA
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Local Institution - 310 - Concord
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Local Institution - 319 - Kingswood
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Local Institution - 323 - Wollongong
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Local Institution - 707 - Maroochydore
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Local Institution - 311 - Woolloongabba
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Local Institution - 308 - Adelaide
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Local Institution - 708 - Adelaide
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Local Institution - 320 - Woodville South
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Local Institution - 709 - Melbourne
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Local Institution - 316 - Murdoch
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Local Institution - 325 - Bankstown
Recruitment hospital [12] 0 0
Local Institution - 330 - Box Hill
Recruitment hospital [13] 0 0
Local Institution - 324 - Sydney, NSW
Recruitment postcode(s) [1] 0 0
2139 - Concord
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2747 - Kingswood
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2500 - Wollongong
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4558 - Maroochydore
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4102 - Woolloongabba
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5000 - Adelaide
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5112 - Adelaide
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5011 - Woodville South
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3004 - Melbourne
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6150 - Murdoch
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2200 - Bankstown
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3128 - Box Hill
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NSW 2050 - Sydney, NSW
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.
Trial website
https://clinicaltrials.gov/study/NCT03440372
Trial related presentations / publications
Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03440372